Newsletter | June 4, 2025

06.04.25 -- Hard Lessons In Parenteral Automatic Visual Inspection

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Webinar: Seals & Stability: Preventing Failures in Synthesis and Chromatography Columns

This webinar highlights the overlooked importance of seals and O-rings in oligonucleotide synthesis and chromatography. Chuck Haeger shares real-world cases showing how proper maintenance and skilled teams prevent failures. Attendees will learn strategies to boost column longevity, reduce risks, and ensure high-quality output—ultimately supporting the production of life-changing medicines. Click here to learn more.

FOCUS ON DOWNSTREAM MANUFACTURING

Hard Lessons In Parenteral Automatic Visual Inspection

Complex problems can have simple solutions. That's what a team at AstraZeneca found when they set out to reduce false rejection rates in vials containing mAbs.

Challenges And Considerations For Purifying Multispecific Molecules

The structural complexity and variability of multispecific molecules presented purification challenges, from incorrect chain pairings to increased aggregation, fragmentation, and lower yield compared to standard mAbs. Developers shared how they overcame these challenges to achieve high purity and discussed key considerations for downstream developers when designing these processes. Bioprocess Online editor Tyler Menichiello explored these questions with Jian Ren, Ph.D., a principal scientist in downstream process development at AbbVie, and Mark Fitchmun, founder, president, and CEO of Somatek.

Increasing Downstream Manufacturing Process Efficiencies

Downstream processing can account for up to 80% of biopharmaceutical production costs. Optimizing this stage is crucial for resource management, product quality, and overall yield.

Stopper Migration In Frozen Pre-Filled Syringes

Review a semi-automated method for dynamically assessing plunger migration under controlled variations in temperature and pressure, utilizing computer vision tools.

Antibody Coverage Analysis Of E. coli HCPs In The BL21(DE3) Strain

Review a study conducted to determine the suitability and similarity of Cygnus E. coli HCP ELISA Kits to quantify BL21(DE3) Host Cell Proteins (HCPs).

Navigating Downstream Bioprocessing For Biosimilar Development

Unlock efficient biosimilar production with expert insights that reveal how advanced purification technologies can significantly reduce costs and meet stringent regulatory demands in today's market.

Real-Life Application Of Intensified Chromatography – See The Results

Explore the impact and benefits of multi-column chromatography, taking into consideration product quality consistency as well as the potential cost and resin savings compared to batch chromatography.

DOWNSTREAM MANUFACTURING SOLUTIONS

Pharma+ Tubing Retainers - Nordson MEDICAL

Looking For A More Affordable Source Of Protein A Resin? - Thermo Fisher Scientific

Be A Gain Changer With 2x Throughput - Cytiva

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Explore the latest biotech equipment and solutions — all online, wherever you are.

Don't miss the next Bio-Expo Live! This interactive, multi-day event is organized by stages of drug development and production, making it easy to find sessions tailored to your company's needs. Browse the full agenda and register for free to join the conversations most relevant to your work.

FOCUS ON FILL-FINISH

Challenges Associated With In-Use Simulated Administration Of Biologics

Explore some of the more challenging aspects surrounding in-use testing for parenteral delivery along with potential strategies to address these issues.

Maximizing Yield And Minimizing Risk In Aseptic Filling

Explore the process of how a new fill line was planned for and implemented, while also considering how best to mitigate contamination risks.

Meeting The Changing Demands For Sterile-Fill Finish Operations

Meeting the growing demand for aseptic fill-finish operations requires specialized expertise, appropriate equipment, and innovations in both emerging technology and business models.

FILL-FINISH SOLUTIONS

In-Depth Protein Analysis With Prometheus Panta C - NanoTemper Technologies, Inc.

The Future Of Glass Packaging Is Here - West Pharmaceutical Services, Inc.

Capacity Update January 2025: Fill/Finish - Alcami

Capacity Update April 2025: Fill/Finish - Catalent

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